Advocacy, Ethics and Access:

How civil society is shaping microbicide research

Manju Chatani, AMAG Anna Forbes, GCM M2008 Pre-Conference Advocates Workshop 24 February, 2008

Where is microbicide advocacy?

Generated at the intersection of women’s health movement and AIDS activism Need first expressed by grassroots women; AIDS and other leadership came later 15 years of sustained activism (since 1992) Microbicide issue catalyzes joint action across Sexual and reproductive health and rights HIV/AIDS and other STIs International development LGBT and women’s rights

Trial Participan t Global community: International NGOs, vaccine trial sponsors and networks, WHO/UNAIDS, other international organizations, international foundations, donors, funders… National community: National NGOs, parliamentarians, Ministries of Health, media, regulatory bodies, ethical review committees… Larger community: NGOs, local policymakers, local media, medical professionals… Immediate community: Participant’s family and friends Surrounding community: CBOs, religious institutions, traditional healers, schools/ universities, microbicide trial site staff, CAB…

BUT end-users must always be the central focus!

Philosophically

demand for microbicides is based on individual’s right to self-determination

Pragmatically

microbicides are user-controlled technology useless if not acceptable and accessible trials impossible without major participant cooperation

Role of advocacy NGOs

Create tools and trainings to help build research literacy and advocacy capacity Help pinpoint key issues -- provide background information and analysis to help frame discussions Provide rapid information on breaking issues to keep everyone up to date Create opportunities for training and strategizing Facilitating networking and information sharing

Current Political Environment

Shaky support among some donors and governments Backlash against NPT advocacy and focus on “things that don’t exist yet” Heightened scrutiny because of recent microbicide and vaccine trial failures

Civil society engagement

In microbicides, generates action across sectors among: Governments and policy makers Researchers and other scientists Funders, trial sponsors and research institutions The media

Enables stake-holders to have a productive impact in the scientific process Requires the conscious creation of effective mechanisms for engagement

The First 55 Steps: A report of the Microbicide Development Strategy’s Civil Society Working Group

“a blueprint for bridging the gap between where we are now (with minimal, scatter-shot and under resourced civil society participation) to where we need to be (with civil society engaging as a full partner).”

Good Participatory Practice Guidelines

Guidance on the responsibilities of trial sponsors and researchers towards participants and their communities Builds engagement among stakeholders which • • minimizes controversy and risk of disruption informs essential acceptability and access work

Global Campaign for Microbicides

works to

Advance dialogue and debate between civil society and researchers on key issues Provide tools and capacity-building for researchers and communities Advocate for approaches that emphasize development and empowerment (not just participation or involvement) Document and disseminate lessons learned

What does it take?

 “scientific literacy” Helping communities learn how clinical trials work and why  “community literacy” Helping researchers learn communities work and how to engage with them  transparency and trust-building Overcoming historically justified suspicion

The tools we use are…

 Training, technical support and resources to local partners to advance work with their own communities  CD Rom – an electronic text book  Microbicides Media and Communications Initiative – to facilitate rapid flow of accurate, objective information about trials  Exploring and advancing work on key trial ethics questions  Cultivating joint advocacy to help research ratchet up health care infrastructure

African Microbicides Advocacy Group

African Regional Network Coordinated African engagement in setting and moving forward the microbicides advocacy and research agenda. Over 500 advocates and researchers from 30 countries across Africa and beyond

“With over 30 clinical trials in Africa, 100s of African researchers and advocates, and 1000s of African trial participants – it is time to amplify realities and needs on the ground.”

AMAG’s focal areas…

Facilitating…

Information sharing, communication & networking Enabling environment for ethical research Enabling environment for access

Engaging… Social: Strengthening local, national and regional level advocacy leadership Political: D emand for women’s HIV prevention options on regional agendas.

Resource mobilisation

to support advocacy, especially in Africa

“How do we empower communities – future users, African researchers and NGOs, women - to be active in this research – to own it, to critique it, to use it?”

Tools and platforms for action…

Collaboration with partner groups Mapping exercises Eforum as platform for dialogue and visibility of emerging issues Meetings and training opportunities Amplifying & highlighting issues/work of local, national groups Ensuring linkages to advocates on the ground

Partnerships support efficient science and human rights, too!

 Trials unlikely to be shut down due to community opposition  Trial participants more candid re: adherence, preferences, behaviors, etc.

 End product more likely to be what target communities want and need  Communities more inclined to host, and benefit from, future trials

Advocacy successes so far..

Increased Resources for the Field Adequate Standard of Care in trials

including contraception at microbicide trial sites & sexual health care for participants

On-going access to care for

HIV positive people screen out of trial & those who seroconvert during a trial

Improved Informed Consent processes Place at the table for advocates Relationships between researchers and advocates on the ground Working with media around trial results Championing emerging issues

Care of trial site counsellors and outreach; communication challenges; local researcher voices; trial participant voices

Reshaping advocacy…

Different levels/kinds of advocacy different information, different players, different strategies Advocates for the need for new options keep the ground-based demand visible, – to Advocates for ethical prevention research – to engage, support and critique research and move forward changing paradigm Advocates for eventual access – to focus on how microbicides (and other products) will eventually come into the hands of women

Advocacy issues pending…

Who are advocates? Messaging – managing expectations, keeping hope alive

“Keeping the faithful faithful”

advocacy?

- long haul interest and Managing information – complexity, trial results, confusions, disappointment Coordination between groups & honest appraisal of partnerships Raising voices of trial participants Integrating microbicides advocacy into existing agendas Holistic approach - other HIV prevention research?

Ethics issues pending…

Pregnancy in trials – care of foetus/mother, access to RH options ARV-microbicides – resistance, 2 nd drugs, HIV+ women line treatment Ensuring dynamic pipeline Strengthening IRBs and ethics committees – whose role is it?

Trials with multiple prevention options – feasible? ethical?

What about research needs of “vulnerable populations”?

Sex workers, Adolescents, HIV positive women, People needing rectal microbicides

Access Issues Pending…

Preferential access to participants Gov’t support to ensuring access Regulatory issues Intellectual property issues Who pays for products?

Industrial level use of products?

Access during Phase 4 trials…

Thank you

Aluta Continua…..